Research Protocol – In its most common sense, methodology is the study of research methods. However, the term can also refer to the methods themselves or to the philosophical discussion of associated background assumptions. A method is a structured procedure for bringing about a certain goal, like acquiring knowledge or verifying knowledge claims. This normally involves various steps, like choosing a sample, collecting data from this sample, and interpreting the data. The study of methods concerns a detailed description and analysis of these processes. It includes evaluative aspects by comparing different methods.
In this way, their benefits and drawbacks are evaluated, as well as the research goals for which they may be used. These descriptions and evaluations are predicated on philosophical background assumptions; examples include how to conceptualize the phenomena under study and what constitutes evidence in favor of or against them. In its broadest sense, methodology encompasses the discussion of these more abstract issues.
Research Protocol
Definition of Research Protocol:
A research protocol is a document that outlines the planning of the study. The plan must be designed to answer the research question and it must also provide a detailed description of the objectives, design, methodology and statistics used.
Steps of Research Protocol Writing:
The following are the steps involved in preparing a research protocol:
➤Title: It should be short (around 15 words) and accurate. It should make the study objectives clear to the reader and, if possible, it should include the key words as well as the type of patients that will be studied.
➤Summary: A brief recapitulation that should make the research objective and its rationale clear. It should also include a summary of the study inclusion and. exclusion criteria, objectives and purpose, as well as the procedures and duration of the study to be conducted.
➤Background: In order to be able to propose a clinical study, first the foundations for the need to conduct that research should be laid. For this reason, this section should detail the background or problems that have been found and have led to the conduct of this study. This section may include references, data or figures of related studies, etc.
➤ Rationale: The background should be followed by a scientific rationale of why it is convenient to conduct the study; i.e., the reasons that support the need to conduct that research. It is important that this section be linked with the previous one, so the reader quickly guess the reasons for the study.
➤Primary and secondary objectives: The primary objective is the purpose of the study and should be very similar to the protocol title, while the secondary objectives aim to obtain additional and more detailed information on important but less
relevant aspects than the primary objective. It involves performing a detailed development of the study and the actions that will be taken. The objectives should be measurable, observable, achievable, and accurate.
➤ Methodology: This section explains the procedures that will be applied to achieve the objectives of the clinical research. The techniques and procedures that will be followed, study design, variables, data collection and analysis, etc. should be detailed here.
➤ Statistical plan: This part can be included in the methodology or in a different section. It should show the methods to be followed in the data analysis according to the type of variables, as well as the software that will be used for data analysis.
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